Replacement Heart-Valve
Basic Information
- Device Name
- Replacement Heart-Valve
- Trade Name
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX
- PMA Number
- P860057
- Supplement Number
- S040
- Device Class
- FDA Class 3
- Product Code
- DYE
- Generic Name
- replacement Heart-valve
- Regulation Number
- 870.3925
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 8, 2006
- Date Received
- October 2, 2006
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE TRADE NAME CHANGE FOR THREE DEVICES, THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX, THE CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2800TFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON RSR PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2800TFX, AND THE CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL MITRAL BIOPROSTHESIS MODEL 6900PTFX TRADE NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL MITRAL BIOPROSTHESIS MODEL 6900PTFX. THE INDICATIONS FOR THE THREE DEVICES REMAIN UNCHANGED.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYE | Replacement Heart-Valve | FDA class 3 | Cardiovascular |